Senior Manager Regulatory Affairs at Cerus Europe B.V.
Amsterdam Area, Netherlands
Cerus Europe B.V.
Senior Manager Regulatory Affairs
July 2015 to Present
Sr. Consultant QA/RA
January 2013 to Present
Manager Quality Control
January 2011 to December 2012
Consultant Medical devices
January 2009 to January 2011
April 2006 to December 2008
Sanquin Blood Supply
2002 to 2006
2001 to 2004
What company does Marcel De Jong work for?
Marcel De Jong works for Cerus Europe B.V.
What is Marcel De Jong's role at Cerus Europe B.V.?
Marcel De Jong is Senior Manager Regulatory Affairs
What industry does Marcel De Jong work in?
Marcel De Jong works in the Medical Devices industry.
Senior Manager Regulatory Affairs @ From July 2015 to Present (1 month) AmersfoortSr. Consultant QA/RA @ Emergo Group is a consulting firm that provides RA/QA consulting services to medical device and IVD manufacturers worldwide. Headquarters in Austin, Texas, with offices in 20+ countries. Background in biotech research & development (IVD's), experimental/test design, technical writing, project and people management. - Compile regulatory submissions such as Technical Files/Design Dossiers for CE marking (MDD 93/42/EEC, IVDD 98/79/EC) - Compile regulatory submissions such as Technical Files/Design Dossiers for Brazil. - Author and maintain clinical evaluation reports in conformance to MEDDEV 2.7/1, Rev. 3 (perform literature searches, data compilation and analysis) - Serve as lead consultant on regulatory research projects by liaising with Emergo Group's worldwide offices. Aid manufacturers in identifying global strategies for successful market entry and requirements for compliance - Assist manufacturers in product assessment and device classification ("Regulatory Strategy Reports") - Strong technical writing skills (medical devices) - Work closely with VP of Global Regulatory Affairs to facilitate client training and external/internal communication - Interact with regulatory authorities and third parties on behalf of medical device manufacturers - Set up quality management systems (ISO 13485 also CMDCAS / ISO 9001) - Internal/supplier auditing - Training (ISO 19011 / ISO 13485 / new Medical device regulations / MDD / IVDD / ISO 14971) - Good knowledge on EU Cosmetics regulations 1223/2009: Review (technical) documentation and submissions in CPNP database. From January 2013 to Present (2 years 7 months) Den Haag/OpmeerManager Quality Control @ The Quality Control department at Medistad B.V. includes the sub departments: - Quality Supervision - Laboratory Services - Incoming Goods From January 2011 to December 2012 (2 years) MedemblikConsultant Medical devices @ CEpartner4U services include on-site and cyber consulting for all products under the medical device directive (MDD), in-vitro diagnostic device directive (IVDD) and active implantable device directive (AIMDD). Authorized Representative, confidentially maintaining your technical file and registering your Class I and IVD products with the Competent Authorities in all EU memberstates. CEpartner4U is staffed with a team of experienced Lead Assessors and medical equipment researchers. Their experience includes: - Project engineering. - Managing a multitude of medical consulting projects and training programs. - Medical product development, market research, development of quality test programs for medical devices, ISO 13485, GMP, hospital quality standards and CE-marking of medical devices - ISO 13485 and sterilization processes assessment and several years of medical device directive (MDD) audits in Europe, Israel and the USA as certified lead assessor for a Notified Body From January 2009 to January 2011 (2 years 1 month) Research Associate @ AcroMetrix offers a range of high quality molecular products designed to meet customer needs. This product range includes controls and standards to assist in the implementation and monitoring of diagnostic assays for clinical laboratories, blood centres and manufacturers. With our combination of well characterized, consistent quality control products and internet-based solutions for interpreting and managing results, we strive to make it easy for laboratories to: validate new assays train laboratory technologists, and set the standard when creating noteworthy quality control programs From April 2006 to December 2008 (2 years 9 months) Research Associate @ - Design, development and production of IVD Medical Devices, i.e. IVD kits, -reagents and -controls and development of IVD analyzers for blood group serology screening applications. - Design, development, production of RUO reagents. - 3rd party OEM IVD reagent development for 2 major IVD manufacturers. From 2002 to 2006 (4 years) Research Associate @ Development of Human IgG subclass reagents (Mouse monoclonal a-IgG3 and IgG4 coupled to latex beads) for use as IVD reagent with clinical analysers (DadeBehring/Siemens, Beckman Coulter) From 2001 to 2004 (3 years) B.Sc., Biochemistry @ Hogeschool Alkmaar From 1997 to 2003 post B.Sc., ISO 19011 audit training @ NEN Dutch Standardisation Institute Marcel De Jong is skilled in: Medical Devices, GMP, Clinical Research, ISO 13485, Quality System, Quality Assurance, Quality Auditing, IVD, IVDD, ISO 14971, Change Control, Change Management, GLP, GDP, Gap Analysis, Stability Studies, Peer Reviews, Training, Regulatory Affairs, Product Development, Production Deployment, Laboratory, FDA, CAPA, Assay Development, Biotechnology, CE marking
Extraversion (E), Sensing (S), Feeling (F), Judging (J)
2 year(s), 4 month(s)
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